Full TitleNon-Comparative, Two-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects after Failure of Autologous Stem Cell Transplant (ASCT)
In this study, researchers are evaluating the safety and effectiveness of nivolumab in patients with classical Hodgkin lymphoma that has returned after autologous stem cell transplantation (ASCT). Nivolumab boosts the body’s immune system by targeting a protein on cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time.
Some cancers take advantage of this shut-down mechanism, enabling them to escape attack by the immune system. Nivolumab binds to and inactivates PD-1, enhancing the body’s immune cells to detect and destroy the lymphoma cells. It is given intravenously (by vein), once every two weeks.
Nivolumab is approved for treating melanoma and some metastatic squamous cell lung cancers; its use for treating other cancers is considered investigational.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have classical Hodgkin lymphoma that has returned after ASCT.
- Patients must not have received brentuximab vedotin prior to ASCT.
- Patients with lymphocyte-predominant Hodgkin lymphoma may not participate.
- At least 90 days must have passed since completion of ASCT and receipt of the first dose of nivolumab.
- At least 4 weeks must have passed since receiving prior chemotherapy or antibody therapy, 10 weeks since radioimmunotherapy, and 3 weeks since radiation therapy and receipt of the first dose of nivolumab.
- Patients may not have previously received anti-PD-L1, anti-PD-L2, anti-PD-1, anti-CD137, or anti-CTLA-4 therapies.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.